two pages) Other Biographical Sketches (Not to exceed two pages for each) ......................................... Other Support ................................................................................. Resources .................................................................................... Research Plan Introduction to Revised Application (Not to exceed 3 pages) ................................................... Introduction to Supplemental Application (Not to exceed on I page) ............................................... A. Specific Aims ................................ _ ....................................... B. Background and Significance ....................... [. ....................................... C. Preliminary Studies/Progress Report _ (lltems A-D: not to exceed Phase I Progress Report (SBIR/STTR Phase II ONLY) J D. Research Design and Methods .................... _ ........................................ E. Human Subjects .............................................................................. Protection of Human Subjects (Required if Item 4 on the Face Page is marked "Yes") Inclusion of Women (Required if Item 4 on the Face Page is marked "Yes") Inclusion of Minorities (Required if Item 4 on the Face Page is marked "Yes") Inclusion of Children (Required if Item 4 on the Face Page is marked "Yes") Data and Safety Monitoring Plan ((Required if Item 4 on the Face Page is marked "Yes" and a trial is proposed) .................................................................. F. Vertebrate Animals ........................................................................... G. Literature Cited ............................................................................... H. Consortium/Contractual Arrangements .............................................................. I. Consultants ................................................................................. J. Product Development Plan (SBIR/STTR Phase II and Fast-Track ONLY) ...................................... Checklist ..................................................................................... *SBIR/STTR Phase I applications: Items A-D of the Research Plan are limited to 15 pages, Appendix (Five collated sets. No page numbering necessary for Appendix) Appendices NOT PERMITTED for Phase SBIR/STTR unless specifically soficited, Number of publications and manuscripts accepted or submitted for publication (not to exceed 10) Other items (list): PHS 398 (Rev. 05/01) Page 3 Number pages consecutively at the bottom throughout the application. Do no_! use suffixes such as 3a, 1 2- 2 3 4 4 ....................... 5 8 i0 12 _ .... 13 }_..... 22 25 pages*) -_ / __-.... 29 39 Phase I, II, or III clerical 39 39 45 45 46 Check if [] Appendix is included 10 Form Page 3 3b.